Date: 2013-06-03
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Company: Boehringer Ingelheim (Germany)
Product: nintedanib
Action
mechanism: tyrosine kinase inhibitor. Nintedanib is an oral triple angiokinase inhibitor that blocks three growth factor receptors simultaneously: vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and beta), and fibroblast growth factor receptors (FGFR 1-3). All three receptors are crucially involved in the formation and maintenance of new blood vessels (angiogenesis); their blockade may lead to the inhibition of angiogenesis, which plays a critical role in tumour growth and spread.Nintedanib is currently being investigated in patients with various solid tumours including advanced NSCLC, ovarian cancer, liver cancer (hepatic cell carcinoma), kidney cancer (renal cell carcinoma), and colorectal cancer.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: LUME-Lung 1 is part of the wider Boehringer Ingelheim LUME-Lung Phase III programme for nintedanib, investigating the safety and efficacy of nintedanib in NSCLC patients after first line chemotherapy treatment. Approximately 2,000 patients were enrolled, making this one of the largest Phase III study programmes in this NSCLC patient population to date.
Latest
news: * On June 3, 2013, results of the LUME-Lung 1 Phase III clinical trial have been presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. These results showed that the novel nintedanib, an oral triple angiokinase inhibitor, extended life by 2.3 months for non-small cell lung cancer (NSCLC) adenocarcinoma patients when added to docetaxel, versus placebo plus docetaxel.LUME-Lung 1 showed an overall survival benefit for a second-line treatment which is added on to chemotherapy, compared to chemotherapy alone. Overall survival was significantly prolonged in the group of adenocarcinoma patients with nintedanib* plus docetaxel versus placebo plus docetaxel (12.6 vs. 10.3 months respectively).The primary endpoint of the trial was progression-free survival (PFS) in second-line treatment of NSCLC patients. The combination of nintedanib plus docetaxel demonstrated a statistically significant prolonged progression-free survival (PFS), versus placebo (3.4 vs. 2.7 months, respectively) regardless of tumour histology.The most common adverse events (AEs) in LUME-Lung 1 were gastrointestinal side effects and liver enzyme elevations which were manageable by supportive treatment or dose reduction (adverse events placebo vs. nintedanib: nausea 18% vs. 24%, vomiting 9% vs. 17%, diarrhoea 22% vs. 42% and liver enzymes 8% vs. 29%). Withdrawal due to adverse events was similar in both arms, as were Grade 3 hypertension, bleeding or thrombosis.
